View News

ALISO VIEJO – Charles Dunlop, founder and CEO of Ambry Genetics, never tested his own DNA even though he had the technology at his fingertips. He refused to displace a vial of a patient’s blood in a lab bursting at capacity.

But after his 2014 diagnosis of Stage 4 prostate cancer, he ran a sample and discovered a mutation in a gene involved in DNA repair, which can increase risk for a number of cancers.

“I had a lab over here for people like me and I didn’t test my own blood because we were so busy,” Dunlop said.

The era of operating on overload has come to an end with Dunlop’s recent unveiling of a highly automated “super lab” that can process three times as many samples per day, at 3,000, while offering faster turnaround times and enhanced quality measures.

“I just want the world to be better and I want to see less suffering,” Dunlop said. “With the new lab, we get to do the job we’ve always wanted to do.”

To that end, Dunlop on Tuesday announced another initiative, AmbryShare.

In an effort to accelerate the quest for cures, the company released anonymous, aggregated genetic testing data for hereditary breast and ovarian cancer for use by researchers. The data comes from the sequencing of 10,000 patient exomes, which make up less than 2 percent of the human genome but include most of the known disease-associated variants.

The company plans to add more data, available for free download to registered users at share.ambrygen.com, at least every quarter.

“What I’m trying to do is give away the data instead of hoard it or sell it to the highest bidder, to the people that actually do the cures,” Dunlop said.

“It’s a very humanistic thing we’re doing and it’s also a very greedy thing we’re doing,” he said. “I have Stage 4 cancer. Did I give my mutation to my daughter? I’d like to think one day there’s a cure if she needs it.”

Dr. Stephen Gruber, director of the USC Norris Comprehensive Cancer Center, said he applied right away to receive the data, calling the announcement “a great day for genomics.” He said the large sample size will be useful for counseling patients who have undergone genetic testing about their risk of disease and will help yield new treatment and prevention approaches.

“The interpretation of these data is the really, really hard part,” Gruber said. “What this allows us to do as a a broader cancer community is to bring to bear all the resources for helping to interpret this data in a way that will accelerate clinical care.”

The opening of the 65,000-square-foot lab, which took a year to build, and the release of the testing data, come after the company won a groundbreaking legal decision that shattered the monopoly on breast cancer testing and then weathered the blow of Dunlop’s cancer diagnosis.

Ambry entered the breast cancer genetic testing market in 2013, a couple of hours after the U.S. Supreme Court ruled that naturally occurring human DNA could not be patented. In March 2014, a federal judge denied a request by a competitor to halt Ambry’s testing for the BRCA 1 and BRCA 2 gene mutations linked to breast and ovarian cancer, which Ambry offered for about half the price.

Three months later, Dunlop, 42 at the time, learned he had advanced prostate cancer, which was diagnosed after he had difficulty urinating. Dunlop had recently become a father for the first time and he feared he would not see his infant daughter grow up. He took a leave from the company and went to Hawaii to focus on his recovery.

His diagnosis brought the company’s mission into even sharper focus.

“When we sequenced Charlie’s sample and found a mutation there, it’s good for employees to realize that what you’re doing matters to individuals. This isn’t just a DNA tube,” said Aaron Elliott, interim chief scientific officer. “It hit home even harder.”

Dunlop’s mutation is not directly linked to prostate cancer and did not effect his treatment plan. But because of his age – prostate cancer is most often diagnosed in men over 65 – Dunlop correctly suspected a genetic component.

He has completed chemotherapy and remains on hormone therapy.

“I am in remission. I have a good energy level. I’m on the job,” he said.

Cancer panels are one of the most popular tests and the new lab will decrease turnaround times from about 21 to 28 days to 14 to 21 days.

“That’s extremely significant,” Elliott said. “A lot of the patients we get are high-risk individuals with a strong family history. Every day matters.”

The privately held company declined to disclose how much the lab cost. Dunlop said he didn’t know how much the exomes would sell for on the open market but said Ambry had been approached by interested pharmaceutical companies.

During Ambry’s grand opening of the new lab last month, Dunlop said he wondered if in 10,000 years people will look back and recall a time when there was still disease, before a genomic revolution discovered life-sparing cures.

“Are we going to be a footnote in history?” Dunlop asked. “I don’t know. We might.”